Currently available nucleic acid amplification platforms for tuberculosis (TB) detection are not designed to be simple or inexpensive enough to implement in decentralized settings in countries with a high burden of disease. The loop-mediated isothermal amplification platform (LAMP) may change this. We conducted a study in adults with symptoms suggestive of TB in India, Uganda, and Peru to establish the feasibility of using TB-LAMP (Eiken Chemical Co.) in microscopy laboratories compared with using smear microscopy against a reference standard of solid and liquid cultures. Operational characteristics were evaluated as well. A total of 1,777 participants met the eligibility criteria and were included for analysis. A pproximately 9 million people developed tuberculosis (TB), and 1.5 million people died from the disease in 2013 (1). Substantial progress has been made in increasing treatment success, but 2.9 million of these cases were not diagnosed or diagnosis was not reported due to limited access to diagnostic tests, insufficient sensitivity, or long turnaround time. More rapid and accurate detection at lower levels of care is necessary to reach these lost and missed cases (2). Nucleic acid amplification tests (NAATs) offer speed and sensitivity for pathogen detection, but until recently, no commercial systems had been designed to be simple or inexpensive enough for decentralized settings (3).Xpert MTB/RIF (Cepheid Inc., Sunnyvale, CA), a rapid automated molecular test, has been a major step in the right direction, but initial investment in the equipment and subsequent maintenance remain quite expensive. The development of a less costly approach through the use of manual techniques may expand the application of NAATs.TB-LAMP is a manual TB detection method that is based on the novel loop-mediated isothermal amplification platform (LAMP) from Eiken Chemical Co. in Japan. LAMP has several features that make it attractive as a diagnostics platform for resource-poor settings. It takes less than 2 h (Ͻ60 min of hands-on time), it is less complex than traditional molecular methods, and it generates a fluorescent result that can be detected with the naked eye (4). In a recent study in peripheral laboratories in China using the TB-LAMP assay, the sensitivities in smear-positive, culturepositive sputum specimens and smear-negative, culture-positive sputum specimens were 92.1% (152/165; 95% confidence interval [CI], 86.9% to 95.3%) and 53.8% (113/210; 95% CI, 47.1% to 60.4%), respectively, using solid culture as a reference. The specificity in culture-negative samples was 98.3% (938/954; 95% CI, 97.3% to 99.0%) (5).In this study, we aimed to evaluate the feasibility and operational characteristics of LAMP in microscopy centers, including Citation Gray CM, Katamba A, Narang P, Giraldo J, Zamudio C, Joloba M, Narang R, Paramasivan CN, Hillemann D, Nabeta P, Amisano D, Alland D, Cobelens F, Boehme CC. 2016. Feasibility and operational performance of tuberculosis detection by loop-mediated isothermal amplification platform in ...
Virtual Organisation Breeding Environments (VBEs) represent an emerging valued added strategy for small and medium enterprises (SMEs), to respond in a competitive way to changing market conditions, through the integration of their capabilities in the configuration of Virtual Organizations. The creation of sustainable VBEs is a challenge that requires new business models based on collaborative and trustable environments. Since the VBE include several types of organisations its business model must consider a multi-value system definition and a multi-stakeholder perspective; that will also call for a new governing approach. This paper presents first attempts in the definition of guidelines for develop Business Models and Governance Rules in VBEs.
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